CHU Caen Service de Cardiologie
Caen, 14033, France
NCT Number: NCT03642730
This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Caen, 14033, France
The primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (CE-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). Such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views.
The secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ultrasound scanning
Time frame: Day 1
Composite measurement that characterizes the echocardiography acquisition of the operator who is being assessed with respect to a 2D reference acquisition The echocardiography acquisition score is a combination of the view type score and the image quality score
Time frame: Day 1
Time to acquisition [in seconds] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%
Time frame: Day 1
Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition [Reproducibility of the probe position and orientation]
Time frame: Day 1
Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition [Geometrical reliability of the probe position and orientation]
Time frame: Day 1
Left ventricular Ejection Fraction [in %] by Simpson's biplane method
Philips Healthcare
Industry
Acronym: EPISODE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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